A protocol for a randomized trial measuring flowmetry in risk areas for pressure ulcer: Hyperoxygenated fatty acids vs olive oil.

BACKGROUND: Pressure ulcers are a common adverse event in healthcare. To date, no flowmetry studies have been conducted to compare hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO) in alleviating this condition. AIMS: To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients. DESIGN: Two-phase experimental study. METHODS: Phase 1 will be conducted with healthy subjects, using a randomised, open study design, evaluating an intrasubject control group. Phase 2 will focus on hospitalised subjects, with a randomised, open study group vs. a control group. DISCUSSION: This Project is undertaken to identify the mechanisms that intervene in the genesis of pressure ulcers and to determine whether there are differences in outcomes between the application of HFA vs. EVOO as a preventive measure The results of this study are of economic importance (due to the price difference between the products used) and will also impact on usual clinical practice for patients with impaired mobility and liable to suffer from pressure ulcers, by considering an alternative to established preventive measures.

Validation of living with chronic illness scale in a type 2 diabetes mellitus population.

BACKGROUND: Worldwide, type 2 diabetes mellitus (T2DM) is one of the most prevalent chronic diseases and one of those producing greatest impact on patients' day-to-day quality of life. Our study aim is to validate the "Living with Chronic Illness Scale" for a Spanish-speaking T2DM population. METHODS: In this observational, international, cross-sectional study, 582 persons with T2DM were recruited in primary care and outpatient hospital consultations, in Spain and Colombia, during the period from May 2018 to June 2019. The properties analysed were feasibility/acceptability, internal consistency, reliability, precision and (structural) content-construct validity including confirmatory factor analysis. The COSMIN checklist was used to assess the methodological/psychometric quality of the instrument. RESULTS: The scale had an adequate internal consistency and test retest reliability (Cronbach's alpha = 0.90; intraclass correlation coefficient = 0.96, respectively). In addition, the instrument is precise (standard error of measurement = 3.34, with values < ½SD = 8.52) and correlates positively with social support (DUFSS) (rs = 0.56), quality of life (WHOQOL-BREF) (rs = 0.51-0.30) and ssatisfaction with life (SLS-6) (rs = 0.50-0.38). The original 26-items version of the scale did not support totally the confirmatory factor analysis. The COSMIN checklist is favourable for all the properties analysed, although weaknesses are detected for structural validity. CONCLUSIONS: The LW-CI-T2DM is a valid, reliable and accurate instrument for use in clinical practice to determine how a person's life is affected by the presence of diabetes. This instrument correlates well with the associated constructs of social support, quality of life and satisfaction. Additional research is needed to determine how well the questionnaire structure performs when robust factor analysis methods are applied.

Effectiveness of a Diabetes Education Program based on Tailored interventions and Theory of Planned Behaviour: Cluster randomized controlled trial protocol.

AIM: To measure the Effectiveness of a Diabetes Education Program for people with T2DM, based on Tailored interventions and the Theory of Planned Behaviour. DESIGN: Cluster randomized controlled clinical trial. METHODS: This multicentre study will be carried out at 30 primary healthcare centres, where 436 persons with Type 2 Diabetes Mellitus (T2DM), aged between 18-75 years, will be recruited. The experimental educational program to be applied is modelled using components obtained from a systematic review and prior qualitative analysis. In addition, a taxonomy of nursing practice is used to standardize the program, based on the Theory of Planned Behaviour as a conceptual model. The intervention will be carried out by community nurses, using ADAPP-Ti® , an application developed with FileMaker Pro v.18. The control group will receive usual care and data will be collected at 6, 12, and 18 months, for both groups. The primary outcome considered will be glycosylated haemoglobin and cardiovascular factors, while the secondary ones will be tobacco consumption, body mass index, barriers to self-care, health-related quality of life, and lifestyle modification. The protocol was approved by the Ethics Committee of the Province of Malaga (Spain) in November 2014. DISCUSSION: The degree of metabolic control in T2DM is not always associated with healthy lifestyles and significant levels of medication are often prescribed to achieve clinical objectives. An intervention focused on needs, based on the best available evidence and a solid conceptual framework, might successfully consolidate appropriate self-care behaviour in this population. IMPACT: The study will result in the publication of an educational program featuring well-defined interventions and activities that will enable clinicians to tailor health care to the individual's needs and to combat treatment inertia in attending this population.

Predictors of health service use by family caregivers of persons with multimorbidity.

BACKGROUND: Informal caregivers of patients with multiple chronic conditions are socially good, promoting the sustainability of a large part of home care provision. However, this very demanding activity causes health problems that increase their own need for health services. This study analyses the use of health services by informal carers, comparing it with the use made by the general population with similar characteristics. METHODOLOGY: Cross-sectional analytical study carried out in the Malaga-Valle Guadalhorce Primary Health Care District (Spain). Healthcare demand and perceived health were measured in the family caregivers, compared to the general population. Strobe Statement for observational studies has been used to strength the report of the results. RESULTS: Final sample consisted of 314 family caregivers together with a subsample of 2.290 non-caregivers taken from data of the National Health Survey. This subsample was paired by gender with our sample. Formal caregivers make fewer annual visits to the health services, with respect to the general population, regardless of the perceived level of health. The difference of the means between those who perceive their health as very poor was 0.11 (95% CI: 0.01 to 0.20) consultations with the family doctor, 0.21 (95% CI: 0.15 to 0.26) consultations with medical specialists and 1.70 (95% CI: 1.52 to 1.87) emergency room attention. Three independent factors were identified that predispose to the increased use of health services: background of greater education achievement (OR 8.13, 95% CI: 1.30 to 50.68), non-cohabitation with the care recipient (OR 3.57, 95% CI: 1.16 to 11.11) and a more positive physical quality of life component (OR 1.06; 95% CI: 1.03 to 1.09). DISCUSSION AND IMPLICATIONS: Intrinsic components of the caregiver reveal their independent relationship with the provision of informal care and the use of health services. A broader vision is needed for the factors that influence the health of these caregivers to develop multipurpose interventions and improve the consistency and effectiveness of the health services offered to the caregiver.

Impact of self-care programmes in type 2 diabetes mellitus population in primary health care: Systematic review and meta-analysis.

AIMS AND OBJECTIVES: To evaluate the effectiveness of self-care programmes in type 2 diabetes mellitus (T2DM) population in primary health care. BACKGROUND: The impact of educational interventions on T2DM has been evaluated in various contexts, but there is uncertainty about their impact in that of primary care. DESIGN: Systematic review and meta-analysis. METHODS: A search was conducted in PubMed, CINAHL, WOS and Cochrane databases for randomised controlled trials carried out in the period January 2005-December 2017, including studies with at least one face-to-face educational interventions. The quality of the evidence for the primary outcome was evaluated using the GRADE System. A meta-analysis was used to determine the effect achieved although only the results classified as critical or important were taken into consideration. Checklist of Preferred Reporting Items for Systematic Reviews and Meta-analyses has been followed. PROSPERO registration Number: CRD42016038833. RESULTS: In total, 21 papers (20 studies) were analysed, representing a population of 12,018 persons with T2DM. For the primary outcome, HbA1 c, the overall reduction obtained was -0.29%, decreasing the effect in long-term follow-up. The quality of the evidence was low/very low due to very serious risk of bias, inconsistency and indirectness of results. Better results were obtained for individual randomised trials versus cluster designs and in those programmes in which nurses leaded the interventions. The findings for other cardiovascular risk factors were inconsistent. CONCLUSIONS: Educational interventions in primary care addressing T2DM could be effective for metabolic control, but the low quality of the evidence and the lack of measurement of critical results generates uncertainty and highlights the need for high-quality trials. RELEVANCE TO CLINICAL PRACTICE: Most of self-care programmes for T2DM in primary care are focused on metabolic control, while other cardiovascular profile variables with greater impact on mortality or patient-reported outcomes are less intensely addressed.

Development and Psychometric Validation of an Instrument to Identify Barriers to Self-Care Among Spanish Patients With Type 2 Diabetes on the Basis of Theory of Planned Behavior.

BACKGROUND: Several instruments are available to evaluate barriers to self-care in people with type 2 diabetes, but with significant psychometric weaknesses and poor theoretical background. OBJECTIVES: To develop and psychometrically validate a questionnaire to identify barriers to self-care in this population on the basis of the theory of planned behavior. METHODS: The study was carried out in 15 primary healthcare centers belonging to the Public Health Care System in Andalusia (Spain). After content validity was confirmed, an initial pilot study was undertaken (n = 54) and the model was evaluated in 2 samples of 205 subjects each to test its configural and metric invariance by confirmatory factor analysis. Internal consistency, test-retest reliability, criterion validity, and interpretability were carried out following COSMIN standards. RESULTS: A 4-factor instrument (intention, subjective norms, perceived control, and attitudes) with 15 items was obtained with a good fit: goodness-of-fit index = 0.92, comparative fit index = 0.93, and root mean square error of approximation = 0.043 (90% confidence interval 0.034-0.052). Cronbach α was 0.78, and test-retest reliability was adequate (intraclass correlation coefficient 0.73; P < .0001). The instrument revealed an adequate criterion validity depending on the treatment complexity and level of metabolic control. Thus, participants with poor self-care scores were more likely to suffer from diabetes-related complications (odds ratio 1.91; 95% confidence interval 1.15-3.1). CONCLUSIONS: A theory-driven instrument is suitable for its use with Spanish people with type 2 diabetes to assess their self-care needs and make tailored recommendations for lifestyle modifications on the basis of their behavioral determinants.

A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial.

Pressure ulcers represent a major current health problem and cause an important economic impact on the healthcare system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids (HOFA), and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than HOFA, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care. STUDY DESIGN: Cost minimization analysis of the results obtained from a noninferiority, triple-blind, parallel, multicenter, randomized clinical trial. Population attending primary healthcare centers in Andalusia (Spain). STUDY SAMPLE: 831 immobilized patients at risk of suffering pressure ulcers. These persons were included in the study and randomly assigned as follows: 437 to the olive oil group and 394 to the HOFA group. At the end of the follow-up period, the results obtained by the olive oil group were not inferior to those of the HOFA group, and did not exceed the 10% delta limit. The total treatment cost for 16 weeks was €19,758 with HOFAs and €9,566 with olive oil. Overall, the olive oil treatment was €10,192 less costly. It has been concluded the noninferiority of olive oil makes this product an effective alternative for the prevention of pressure ulcers in patients who are immobilized and in a domestic environment. This treatment enables considerable savings in direct costs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01595347. Date: 2011-2013.

[Spanish cultural adaptation and psychometric validation of the Summary of Diabetes Self-Care Activities measure (SDSCA) among persons with type 2 diabetes mellitus]. / Adaptación cultural al español y validación psicométrica del Summary of Diabetes Self-Care Activities measure (SDSCA) en personas con diabetes mellitus tipo 2.

OBJECTIVE: To undertake the cultural adaptation and the psychometric assessment of the Summary of Diabetes Self-Care Activities measure (SDSCA) in Spanish population with type 2 diabetes mellitus. DESIGN: Clinimetric validation study. SETTING: Primary health care centers of District Malaga and Valle del Guadalhorce. PARTICIPANTS: Three hundred thirty-one persons with type 2 diabetes mellitus. MAIN MEASUREMENTS: The SDSCA validated in mexican population was subjected to semantic and content equivalence using a Delphi method, its legibility was determined by INFLESZ scale. Subsequently psychometric validation was conducted through exploratory and confirmatory factor analysis (herein after EFA and CFA), internal consistency, test-retest reliability and discriminant validity. RESULTS: Two rounds were needed to achieve the consensus in between the panel members. Then, the index provided a good readability. The EFA suggested a model with 3 factors (diet, exercise and self-analysis) with 7 items which explained 79.16% variance. The results of CFA showed a good fit of SDSCA-Sp. The Internal consistency was moderate to low (α-Cronbach =0.62) and test-retest reliability was evaluated in 198 patients (t=0.462-0.796, p<0.001) with a total correlation of 0.764 (p< 0.0001). CONCLUSIONS: The SDSCA-Sp is used, in a valid way to assess self-care in type 2 DM version in clinical practice and research with similar clinimetric properties to previous studies.

Using qualitative methods in developing an instrument to identify barriers to self-care among persons with type 2 diabetes mellitus.

AIMS AND OBJECTIVES: To develop a questionnaire to address barriers and self-care behaviour among persons with type 2 diabetes mellitus. BACKGROUND: Several instruments are available in the literature to measure barriers to self-care in this population, but many of them present limitations in its psychometric validation process, and lack of theoretical background. DESIGN: Content validation study using multiple qualitative methods. METHODS: A systematic review was conducted, and two focus groups with fifteen participants (n = 15) were analysed to identify key topics and categories concerning barriers and self-care behaviour. These categories were used to generate items that were subjected to expert scrutiny, using the Delphi technique. The resulting list of items was tested for readability and comprehension by nine diabetic patients (n = 9), through cognitive interviews. The whole process was conducted in accordance with the Theory of Planned Behaviour. RESULTS: The mean age (standard deviation) of participants in the focus groups and cognitive interviews was 66·05 (8·47) and 63·11 (6·13) years, respectively. 46·7% of the members of the focus groups and 44·4% of those interviewed were female, and the mean duration (standard deviation) of their diabetes was 6·53 (3·17) and 4·89 (3·84) years, respectively. After the qualitative analysis, 27 codes were obtained. Thereafter, items were generated in accordance with the dimensions of this theory: attitudes towards the behaviour (n = 23), social norms (n = 13), perceived behavioural control (n = 17) and behavioural intention (n = 15). CONCLUSIONS: A rigorous process of content validation with multiple methods was implemented to obtain an instrument aimed at addressing barriers and self-care behaviour of patients with type 2 Diabetes Mellitus. RELEVANCE TO CLINICAL PRACTICE: An instrument theoretically rooted and supported on professional and patients' views is available to assess self-care behaviours in patients with type 2 Diabetes Mellitus. The evaluation of its reliability and construct validity will determine the instrument's value and practical application in the clinical context.

Systematic review of the psychometric properties and theoretical grounding of instruments evaluating self-care in people with type 2 diabetes mellitus.

AIM: To determine the psychometric properties and theoretical grounding of instruments that evaluate self-care behaviour or barriers in people with type 2 diabetes. BACKGROUND: There are many instruments designed to evaluate self-care behaviour or barriers in this population, but knowledge about their psychometric validation processes is lacking. DESIGN: Systematic review. DATA SOURCES: We conducted a search for psychometric or validation studies published between January 1990-December 2012. We carried out searches in Pubmed, CINAHL, PsycINFO, ProQuolid, BibliPRO and Google SCHOLAR to identify instruments that evaluated self-care behaviours or barriers to diabetes self-care. REVIEW METHODS: We conducted a systematic review with the following inclusion criteria: Psychometric or clinimetric validation studies that included patients with type 2 diabetes (exclusively or partially) and which analysed self-care behaviour or barriers to self-care and proxies like self-efficacy or empowerment, from a multidimensional approach. Language: Spanish or English. Two authors independently assessed the quality of the studies and extracted data using Terwee's proposed criteria: psychometrics properties, dimensionality, theoretical ground and population used for validation through each included instrument. RESULTS: Sixteen instruments achieved the inclusion criteria for the review. We detected important methodological flaws in many of the selected instruments. Only the Self-management Profile for Type 2 Diabetes and Problem Areas in Diabetes Scale met half of Terwee's quality criteria. CONCLUSION: There are no instruments for identifying self-care behaviours or barriers elaborated with a strong validation process. Further research should be carried out to provide patients, clinicians and researchers with valid and reliable instruments that are methodologically solid and theoretically grounded.

A systematic review of the effectiveness and roles of advanced practice nursing in older people.

OBJECTIVES: To identify, assess and summarize available scientific evidence about the effect of interventions deployed by advanced practice nurses when providing care to older people in different care settings, and to describe the roles and components of the interventions developed by these professionals. BACKGROUND: In older people, evidence of advanced practice roles remains dispersed along different contexts, approaches and settings; there is little synthesis of evidence, and it is not easy to visualize the different practice models, their components, and their impact. DESIGN: Systematic review. DATA SOURCES: Sixteen electronic databases were consulted (1990-2014). The research also included screening of original studies in reviews and reports from Centers of Health Services Research and Health Technology Agencies. REVIEW METHODS: Studies were assessed by two reviewers with the Cochrane risk of bias tool. They were classified depending on the type of follow-up (long and short-term care) and the scope of the service (advanced practice nurses interventions focused on multimorbid patients, or focused on a specific disease). RESULTS: Fifteen studies were included. In long-term settings, integrative, multi-component and continuous advanced practice nursing care, reduced readmissions, and increased patients' and caregivers' satisfaction. Advanced practice nurses were integrated within multidisciplinary teams and the main interventions deployed were patient education, multidimensional assessments and coordination of multiple providers. CONCLUSION: Positive results have been found in older people in long-term care settings, although it is difficult to discern the specific effect attributable to them because they are inserted in multidisciplinary teams. Further investigations are needed to evaluate the cost-effectiveness of the two modalities detected and to compare internationally the interventions developed by advanced practice nurses.

Adaptación cultural al español y validación psicométrica delSummary of Diabetes Self-Care Activities measure (SDSCA) en personas con diabetes mellitus tipo 2 / Spanish cultural adaptation and psychometric validation of the Summary of Diabetes Self-Care Activities measure (SDSCA) among persons with type 2 diabetes mellitus

OBJETIVO: Llevar a cabo la adaptación cultural y la validación psicométrica del Summary of Diabetes Self-Care measure (SDSCA) en población española con diabetes mellitus tipo 2. DISEÑO: Estudio de validación clinimétrica. Emplazamiento: Centros de atención primaria del Distrito Sanitario Málaga-Valle del Guadalhorce. PARTICIPANTES: 331 personas con diabetes mellitus tipo 2. MEDICIONES PRINCIPALES: La versión validada en población mexicana del SDSCA fue sometida a equivalencia semántica y de contenido mediante un Delphi de expertos, su legibilidad fue determinada mediante la escala INFLESZ. Posteriormente se llevó a cabo la validación psicométrica, evaluándose validez de constructo mediante análisis factorial exploratorio y confirmatorio (en adelante AFE y AFC), consistencia interna, fiabilidad test-retest y validez discriminante. RESULTADOS: Dos rondas fueron necesarias para alcanzar consenso entre los miembros del panel, posteriormente INFLESZ aportó una buena legibilidad. El modelo trifactorial (dieta, ejercicio físico y autoanálisis) con 7 ítems explicaba un 79,16% de la varianza. El análisis confirmatorio mostró un buen ajuste del modelo del SDSCA-Sp. La consistencia interna fue moderada-baja (α-Cronbach=0,62) y la fiabilidad test-retest fue evaluada en 198 pacientes (t=0,462-0,796, p < 0,001) con una correlación global de 0,764 (p < 0,0001). CONCLUSIONES: El SDSCA-Sp en una versión válida en la práctica clínica y en investigación para evaluar autocuidados en diabetes mellitus tipo 2 con propiedades clinimétricas similares a las obtenidas en estudios previos

OBJECTIVE: To undertake the cultural adaptation and the psychometric assessment of the Summary of Diabetes Self-Care Activities measure (SDSCA) in Spanish population with type 2 diabetes mellitus. DESIGN: Clinimetric validation study. SETTING: Primary health care centers of District Malaga and Valle del Guadalhorce. PARTICIPANTS: Three hundred thirty-one persons with type 2 diabetes mellitus. MAIN MEASUREMENTS: The SDSCA validated in mexican population was subjected to semantic and content equivalence using a Delphi method, its legibility was determined by INFLESZ scale. Subsequently psychometric validation was conducted through exploratory and confirmatory factor analysis (herein after EFA and CFA), internal consistency, test-retest reliability and discriminant validity. RESULTS: Two rounds were needed to achieve the consensus in between the panel members. Then, the index provided a good readability. The EFA suggested a model with 3 factors (diet, exercise and self-analysis) with 7 items which explained 79.16% variance. The results of CFA showed a good fit of SDSCA-Sp. The Internal consistency was moderate to low (α-Cronbach =0.62) and test-retest reliability was evaluated in 198 patients (t=0.462-0.796, p < 0.001) with a total correlation of 0.764 (p< 0.0001). CONCLUSIONS: The SDSCA-Sp is used, in a valid way to assess self-care in type 2 DM version in clinical practice and research with similar clinimetric properties to previous studies